REACH restriction process. REACH Conference Bratislava September 3-4, 2018

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1 REACH restriction process Alena Pilváňová, MSc. Ekotox Centers Ekotoxikologické centrum Bratislava s.r.o. Tomášikova 10/F, Bratislava Tel/Fax.: / ekotox@ekotox.eu REACH Conference Bratislava September 3-4, 2018

2 Overview 1. Restrictions under REACH 2. Overview of restrictions process 3. Actors affected by a restriction 4. Shortcomings and need for action 5. Interplay between Authorisation and Restriction 6. Conclusions

3 How do restrictions work in REACH? a tool to protect human health and the environment from unacceptable risks posed by chemicals may limit or ban the manufacture, placing on the market or use of a substance on its own, in a mixture or in an article including those that do not require registration also apply to imports ECHA can also propose a restriction on articles containing substances that are on the Authorisation List (Annex XIV)

4 Restrictions procedure form of the restriction process is similar to Directive 76/769/EEC - Marketing and Use Directive process of restriction is described by Articles of REACH take many forms: general bans on all uses; bans on specific uses (e.g., as a flame retardant); a ban for products available to the general public; or limits on the concentration of the substance in consumer products such as tyres, clothing or jewellery

5 Exemptions from restrictions do not apply to: the manufacture, placing on the market and use of a substance for scientific research and development (PPORD); the use of a substance as an on-site isolated intermediate; the use of substances in cosmetic products as defined in Directive 76/768/EEC, with regards to restrictions addressing the risks to human health within the scope of that Directive entries 1 58 of Annex XVII, the restrictions do not apply to the storage, keeping, treatment, filling into containers, or transfer from one container to another of the substances for export (unless the manufacture of the substance is prohibited).

6 Overview of restrictions process Submitter (MS or ECHA) Interested Parties ECHA, Committees (RAC, SEAC), Forum, Secretariat Commission Industry Member States Preparatory Work Notified Registry of Intentions Prepare restriction dossier (12 months) Dossier submitted Conformity check Additional Information Public consultation (6 months) Public consultation on SEAC draft opinion (60 days) SEAC prepare and adopt draft SEAC final opinion RAC prepare and adopt an opinion Advice from Forum Prepare decision (3 months) Amend Annex XVII and publish in the Officila Journal Comply Enforce

7 Who is affected by a restriction? anyone who manufactures, imports, uses or supplies substances (on their own, in a mixture, or in an article) could potentially be affected by a restriction 1. Manufacturers and importers of substances 2. Producers and importers of articles 3. Substance/mixture suppliers 4. Downstream users of chemicals

8 1. Manufacturers and importers of substances on its own or in a mixture should check whether this is permitted under the conditions of the restriction registered substances ECHA will inform you if a notification is submitted to RoI ( to plan for and contribute to the public consultation process if you wish to do so, to communicate with others in your supply chain to coordinate your contributions

9 2. Producers and importers of articles articles containing a restricted substance - need to check whether this is allowed or whether the article complies with any limits set importers may have limited knowledge of the chemical substances used to produce the products Column 2 of Annex XVII gives information on the types of product to which the restriction applies

10 3. Substance/mixture suppliers to check that the supply is still permitted under the restriction need to communicate information about the restriction down the supply chain if a SDS required - information about the restriction should be included in Section 15 if a SDS is not required - need to provide the information in a separate communication

11 4. Downstream users supplier should advise you whether the substances they supply are subject to a restriction (in Section 15 of the SDS or in a separate communication if a SDS is not required) compare the conditions of the restriction with your conditions of use, your risk management measures and the mixtures or articles you produce a formulator a mixture component is a subject to a restriction, include information on the restriction in the SDS, or in a separate communication if a SDS is not required

12 Status of received restrictions per year Source: ECHA General Report 2017

13 Current status Annex XVII 68 entries RoI 47 entries intentions or submitted (5 withdrawns) PAHs limit in plastic or rubber garnules used for sport pitches and playgrounds (Netherlands) Oxo-degradable plastics and microplastics in products for proffessional and consumer use (ECHA) Tattoo inks and permanent make-up (ECHA)

14 Benefits outweigh the costs Challenging to estimate Benefits annual human health related benefits from restrictions processed under REACH since 2009, were estimated at over EUR 700 million per annum adopted restrictions were estimated to reduce emissions of PBTs, vpvbs and other substances of concern by about 190 tonnes per annum furthermore, there were other positive impacts from the restrictions for at least consumers and workers, the value of which could not be estimated Costs estimated annual cost of all restrictions for which ECHA s committees gave favourable opinions during was about EUR 300 million five most expensive restrictions represent around 88 % of the total costs Source: ECHA Report on The Operation of REACH and CLP. ECHA-16-R-08-EN.

15 Procedure improvement two distinct EU risk management approaches: a) Restrictions enable the EU to impose conditions on the manufacturing, placing on the market or use of substances b) Authorisation is designed to ensure that substances of very high concern (SVHCs) are used safely while promoting substitution by suitable alternatives recent evaluation has identified a number of shortcomings and need for action: simplification of the process; quicker decision making; improvements in efficiency. Source: Commission General Report on the operation of REACH and review of certain elements, Brussels, COM(2018) 116 final,

16 Interplay between Authorisation / Restriction (1) Practical Considerations Industry Costs Authorisation Fee: 50,000 + Expenses from authorisation application Restriction Less expenses for industry (participation in public consultation) Involvement Direct involvement/active role Reaction to public consultation Different effects Existence of Alternatives Enforcement Legal requirements start from inclusion in Candidate List If granted, Authorisation allows continue use but only for some time Industry to provide information on alternatives Existence of alternatives (or not) has more direct legal consequences Difficult to enforce: applicant -specific (and its supply-chain) No legal requirements during the restriction process If adopted, restriction or ban may no longer allow continued use Information provided by authorities Industry can comment on this is during consultation process Easier to enforce: all actors at the same time

17 Interplay between Authorisation / Restriction (2) restrictions/authorisations powerfull policy measures aimed at limiting human exposure to the chemical concerned but somtimes a substance might be a subject of both LMW (lower molecular weight) phthalates case DIBP, BBP, DBP and DEHP Placing on the market of articles containing BBP, DEHP, DBP and DiBP for indoor environments and direct exposure (submitted, DK 2011) Restriction under Article 69(2) on the four classified phthalates in articles. Depending on the outcome of the assessment, the scope of the restriction might be broad or targeted specifically to articles or article groups that are the main contributors to exposure of the general population. (submitted, DK 2016) Background information on the current regulatory status: DIBP and BBP are no longer used in Europe as there was no Authorisation dossier submitted for these substances by the sunset date of February DBP is authorised in very limited specific industrial applications. DEHP : Authorisation for use in producing original PVC compounds and articles has been recommended by ECHA and while official confirmation by the European Commission is still pending the substances can currently be safely used in those applications for which an Authorisation request was submitted.the recycling of flexible vinyl containing DEHP has also been Authorised for several companies and recently ECHA has recommended re-authorisation of such recycling.

18 Conclusions The REACH Restriction process, as such, represent significant challenges and may cause delisting of chemicals in key industrial applications. The number of new restrictions has so far not met the original expectations. Although the process has improved as a result of the actions initiated after the 2013 REACH review, there is room for further improvement. In the meantime, companies must roll up their sleaves to face the complex challenges ahead!